Vasculogenic Erectile DysfunctionNCT02152683
Linear Focused Shockwave Treatment for Erectile Dysfunction
A study testing Renova in people with Vasculogenic Erectile Dysfunction, run by Initia at 1 site in United States.
Trial summary
The study is aimed at comparing the performance of protocols employing one and two sessions per week, respectively. The study hypothesis claims that there is no significant difference between the performances of the compared protocols. Read more about this study
- Who is it for?
- Ages 20 to 80 years, men only
- Conditions the study is for
- Vasculogenic Erectile Dysfunction
- What is being tested?
- Renova
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Good general health
- Vasculogenic ED- Erectile Dysfunction, according to physician judgment, for at least 6 months and for no longer than 5 years.
- International Index of Erectile Function 6 (IIEF-EF) between 17 and 25
- Satisfactory response to the use of PDE5 (Phosphodiesterase type 5) inhibitors
- Stable sexual relationship for at least 3 months prior to treatment
- Minimum of two sexual attempts per month
Who cannot join
- Hormonal, neurological or psychological pathology
- Past radical prostatectomy or extensive pelvic surgery
- Recovering from cancer during last year
- Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
- Clinically significant chronic hematological disease
- Anti-androgens, oral or injectable androgens
- Past radiotherapy treatment of the pelvic region
- International normalized ratio (INR) > 3 for patients using blood thinners (such as Coumadin)
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastchester Center for Cancer Care
New York, New York, 10469
About this study
The study is aimed at comparing the performance of protocols employing one and two sessions per week, respectively. The study hypothesis claims that there is no significant difference between the performances of the compared protocols.
- Conditions
- Vasculogenic Erectile Dysfunction
- Being tested
- Renova
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RenovaDevice
Low- Intensity Shockwave
| Study group | Role | What they receive |
|---|---|---|
| long protocol | Experimental | Renova Receives: Device: Renova |
| short protocol | Experimental | Renova Receives: Device: Renova |
What is being measured
The primary outcome is the main question the study is designed to answer.
IIEF-EF- International Index of Erectile Function questionnaire score
the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment
Measured: 1 month post treatment
IIEF-EF questionnaire score
Measured: 3 months post treatment
IIEF-EF questionnaire score
the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment
Measured: 6 months post treatment
Secondary outcomes (3)
SEP- Sexual Encounter Profile: Questions 2 and 3
Measured: 1, 3 and 6 months post treatment
GAQ- Global Assessment Questions
Measured: 1, 3 and 6 months post treatment
EHS- Erection Hardness Score
Measured: 1, 3 and 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vasculogenic Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Initia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152683
- Sponsor's protocol ID
- LISW-NY
- Status last verified
- Sep 2015
- First submitted
- 22 May 2014
- Last updated
- 11 Aug 2022
- Results posted
- No
Publications
Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j.eururo.2010.04.004. Epub 2010 May 6.
PubMed 20451317Goyal NK, Garg M, Goel A. Re: Does low intensity extracorporeal shock wave therapy have a physiological effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study: Y. Vardi, B. Appel, A. Kilchevsky and I. Gruenwald. J Urol 2012; 187: 1769-1775. J Urol. 2012 Nov;188(5):2018-9. doi: 10.1016/j.juro.2012.07.052. Epub 2012 Sep 20. No abstract available.
PubMed 22999553Rosen RC, Cappelleri JC, Gendrano N 3rd. The International Index of Erectile Function (IIEF): a state-of-the-science review. Int J Impot Res. 2002 Aug;14(4):226-44. doi: 10.1038/sj.ijir.3900857.
PubMed 12152111Rosen RC, Allen KR, Ni X, Araujo AB. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Eur Urol. 2011 Nov;60(5):1010-6. doi: 10.1016/j.eururo.2011.07.053. Epub 2011 Jul 30.
PubMed 21855209
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linear Focused Shockwave Treatment for Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT02152683
- Acronym / sponsor ID
- LISW-NY
- Conditions
- Vasculogenic Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 84 participants (actual)
- Lead sponsor
- InitiaIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is aimed at comparing the performance of protocols employing one and two sessions per week, respectively. The study hypothesis claims that there is no significant difference between the performances of the compared protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| long protocol | Experimental | Device: RenovaRenova |
| short protocol | Experimental | Device: RenovaRenova |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Good general health
- Vasculogenic ED- Erectile Dysfunction, according to physician judgment, for at least 6 months and for no longer than 5 years.
- International Index of Erectile Function 6 (IIEF-EF) between 17 and 25
- Satisfactory response to the use of PDE5 (Phosphodiesterase type 5) inhibitors
- Stable sexual relationship for at least 3 months prior to treatment
Key exclusion criteria (8 listed)
- Hormonal, neurological or psychological pathology
- Past radical prostatectomy or extensive pelvic surgery
- Recovering from cancer during last year
- Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
- Clinically significant chronic hematological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RenovaLow- Intensity Shockwave | Device | long protocol, short protocol |
Primary outcome
IIEF-EF- International Index of Erectile Function questionnaire score
Time frame: 1 month post treatment
the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment
IIEF-EF questionnaire score
Time frame: 3 months post treatment
IIEF-EF questionnaire score
Time frame: 6 months post treatment
the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment
3 secondary outcomes
SEP- Sexual Encounter Profile: Questions 2 and 3
Time frame: 1, 3 and 6 months post treatment
GAQ- Global Assessment Questions
Time frame: 1, 3 and 6 months post treatment
EHS- Erection Hardness Score
Time frame: 1, 3 and 6 months post treatment
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Background: PubMed 20451317Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j.eururo.2010.04.004. Epub 2010 May 6.
- Background: PubMed 22999553Goyal NK, Garg M, Goel A. Re: Does low intensity extracorporeal shock wave therapy have a physiological effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study: Y. Vardi, B. Appel, A. Kilchevsky and I. Gruenwald. J Urol 2012; 187: 1769-1775. J Urol. 2012 Nov;188(5):2018-9. doi: 10.1016/j.juro.2012.07.052. Epub 2012 Sep 20. No abstract available.
- Background: PubMed 12152111Rosen RC, Cappelleri JC, Gendrano N 3rd. The International Index of Erectile Function (IIEF): a state-of-the-science review. Int J Impot Res. 2002 Aug;14(4):226-44. doi: 10.1038/sj.ijir.3900857.
- Background: PubMed 21855209Rosen RC, Allen KR, Ni X, Araujo AB. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Eur Urol. 2011 Nov;60(5):1010-6. doi: 10.1016/j.eururo.2011.07.053. Epub 2011 Jul 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renova in people with Vasculogenic Erectile Dysfunction, run by Initia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IIEF-EF- International Index of Erectile Function questionnaire score (time frame: 1 month post treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02152683, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.